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Effect of cardiac rehabilitation versus control group on improving the psychological characteristics of patients undergoing coronary artery bypass graft surgery: a randomized clinical trial

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History
# Registration date Revision Id
2 2023-07-20, 1402/04/29 273796
1 2021-03-31, 1400/01/11 176718
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  • Protocol summary

    This is a randomized clinical trial, phase II, in which 40 eligible patients will be randomly assigned to the intervention and control groups
    This is a randomized clinical trial, phase II, in which 60 eligible patients will be randomly assigned to the intervention and control groups
    این یک مطالعه کارآزمایی بالینی تصادفی شده می باشد که در آن 40 بیمار واجد شرایط به صورت تصادفي به دو گروه مداخله و کنترل تخصیص داده خواهند شد
    این یک مطالعه کارآزمایی بالینی تصادفی شده می باشد که در آن 60 بیمار واجد شرایط به صورت تصادفي به دو گروه مداخله و کنترل تخصیص داده خواهند شد

  • General information

    40
    60
    empty
    Due to increasing the number patients for improving the results
    empty
    به دلیل افزایش تعداد بیماران به منظور تقویت نتیجه مطالعه

  • Primary outcomes

    #1
    Before the intervention and 4 months later
    Before the intervention and 4 weeks later
    قبل از مداخله و 4 ماه بعد از آن
    قبل از مداخله و 4 هفته بعد از آن

Protocol summary

Study aim
To assess the effect of cardiac rehabilitation versus control group on improving the psychological characteristics of patients undergoing coronary artery bypass graft surgery
Design
This is a randomized clinical trial, phase II, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients who are candidate for coronary artery bypass graft surgery referring to the Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 40 to 70 years, Candidate for undergoing coronary artery bypass graft surgery, Ability to read and enough understanding, Ability to perform sport exercise, Exclusion criteria: Limb defect, History of cardiac rehabilitation, History of previous cardiac surgery, Emergency cardiac surgery, Coronary artery bypass graft surgery with valve replacement, History of mental disorder, Taking sedatives or anti-anxiety drugs
Intervention groups
Intervention group: Routine care after coronary artery bypass graft surgery plus physical exercise and physiotherapy for cardiac rehabilitation in accordance with patient’s cardiovascular status (including walking on a treadmill, stationary biking, walking, jogging, aerobics and stretching exercises) 60-minute sessions three times a week for one month. Control group: Just care after coronary artery bypass graft surgery
Main outcome variables
Primary outcome: Mean score of psychological indexes

General information

Reason for update
Due to increasing the number patients for improving the results
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N389
Registration date: 2021-03-31, 1400/01/11
Registration timing: prospective

Last update: 2023-08-01, 1402/05/10
Update count: 1
Registration date
2021-03-31, 1400/01/11
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cardiac rehabilitation versus control group on improving the psychological characteristics of patients undergoing coronary artery bypass graft surgery: a randomized clinical trial
Public title
Effect of cardiac rehabilitation versus control group on improving the psychological characteristics of patients undergoing coronary artery bypass graft surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 40 to 70 years, Candidate for undergoing coronary artery bypass graft surgery, Ability to read and enough understanding, Ability to perform sport exercise,
Exclusion criteria:
Limb defect, History of cardiac rehabilitation, History of previous cardiac surgery, Emergency cardiac surgery, Coronary artery bypass graft surgery with valve replacement, History of mental disorder, Taking sedatives or anti-anxiety drugs
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-10-03, 1399/07/12
Ethics committee reference number
IR.UMSHA.REC.1399.564

Health conditions studied

1

Description of health condition studied
Psychological characteristics
ICD-10 code
F89
ICD-10 code description
Unspecified disorder of psychological development

Primary outcomes

1

Description
Mean score of psychological indexes (including physical complaints, obsession, sensitivity, depression, anxiety, aggression, phobia, paranoid thoughts and psychosis)
Timepoint
Before the intervention and 4 weeks later
Method of measurement
Using Symptom Checklist-90 (SCL90-R)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Routine care after coronary artery bypass graft surgery plus physical exercise and physiotherapy for cardiac rehabilitation in accordance with patient’s cardiovascular status (including walking on a treadmill, stationary biking, walking, jogging, aerobics and stretching exercises) 60-minute sessions three times a week for one month.
Category
Rehabilitation

2

Description
Control group: Just care after coronary artery bypass graft surgery
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Heart Hospital in Hamadan city
Full name of responsible person
Samira Yadollahifar
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
samirayadollahi67@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samira Yadollahifar
Position
Master in Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
samirayadollahi67@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Akbari
Position
Master in Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
aakbari4973@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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